Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials

Table 4 Adverse events, safety population

Outcome	Dabigatran 220 mg	Enoxaparin 40 mg
Outcome	(n = 2,156), n (%)	(n = 2,157), n (%)
AEs during treatment
Total with AEs	1,563 (72.5)	1,588 (73.6)
Serious AEs	146 (6.8)	141 (6.5)
AEs leading to treatment discontinuation	134 (6.2)	118 (5.5)
Drug-related AEs (investigator evaluation)	191 (8.9)	199 (9.2)
Wound infections^a	16 (0.7)	21 (1.0)
Cardiovascular events
Myocardial infarction	2 (<0.1)^b	6 (0.3)
Ischemic stroke	0	1 (0.1)
ALT elevation; no. (%) patients
>3 x ULN anytime post baseline	71/2,101 (3.4)^c	115/2,097 (5.5)^c
>3 x ULN plus bilirubin >2 x ULN during treatment period	3/2,092 (0.1)^d	0/2,096

Data are given as number (%) of patients except where indicated
AE adverse event, ALT alanine aminotransferase, ULN upper limit of normal
^aIncludes wound hematomas, wound secretions, wound drainage and wound hemorrhage; ^bA further event in RE-NOVATE II occurred in the follow-up period; ^cNumber of patients with abnormality/total number of patients having tests; ^dA further patient in RE-NOVATE II had an elevation 3 months postsurgery while still in the follow-up period. None of the patients met the criteria for severe drug-induced hepatotoxicity [12]. One of these patients was diagnosed with acute cholangitis but a definitive diagnosis was not made in the other patient

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